Associate Clinical Scientist, early phase clinical trials

Job description

Job Description

As an Associate Clinical Scientist, you support Clinical Scientists by contributing to the running of clinical studies as part of a clinical trial team. You may also have other responsibility delegated by the Clinical Scientist (e.g., vendor management, country/region responsibility) and work independently within the team.

1. Support the global multidisciplinary Clinical Trial Team (CTT) to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices. Undertake defined responsibilities delegated by the Clinical Scientist, including regional management of study conduct, and/or vendor oversight of study related tasks
2. Attend CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines and quality standards
3. In collaboration with outsourcing/planning/feasibility personnel, CTT members, local country office representatives and CRAs, support the identification sites and manage study set-up, including support for organizing Investigator meetings or Site Initiation meetings
4. Interact with investigator sites and CRAs/CROs/vendors and support Clinical Scientists to ensure smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised
5. Contribute to the development of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents
6. Support Clinical Scientists in ordering and management of clinical trial materials, including investigational medicinal product, CRFs, laboratory kits, and other clinical supplies
7. Regularly update all trial information databases in order to manage accuracy of information. Including internal CTMS systems and external databases according to Novartis disclosure policies and individual country regulations
8. In collaboration with the Medical Expert and CTT, support the ongoing medical / scientific review of the clinical trial data, and the data analysis. Assist in data review and interactions with the Data Manager, Statistician, and any third parties to ensure high quality data are transferred/available in a timely manner
9. Support the Clinical Study Report writing; either by directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements

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About Clinical Sciences & Innovation:

Clinical Sciences & Innovation (CS&I) is part of Translational Medicine, a single global team of Physicians and Scientists that bridge drug discovery and clinical application and includes Biomarker Development, Discovery & Profiling (Physician-Scientists), Drug Metabolism & Pharmacokinetics, and Pre-Clinical Safety.

The CS&I group is a global team of Clinical Scientists and support functions that plan and manage Novartis Institutes for BioMedical Research Phase I and Phase IIa clinical trials worldwide. Our trials profile safety, tolerability, pharmacokinetics, pharmacodynamics, and early proof of efficacy of novel compounds in healthy volunteers and patients: key tasks include leading authorship of study protocols and input to study designs, identifying study sites and investigators, negotiating external study contracts, co-ordinating study execution and monitoring enrolment and data flow/scientific review.
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Desired profile

Minimum requirements

- PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences
- Business-level oral and written English

- Approximately 1-3 years hands-on demonstrated experience in a clinical trial management / execution position within a sponsor, full-service CRO or Clinical Trials unit. (This position cannot support those from a non-clinical trial management background)
- Multi-site experience: ideally from multi-country trials, otherwise from a single large multi-site country
- Knowledge of Good Clinical Practice
- Office and clinical trial software IT computer literacy
- Demonstrated organizational skills
- Clear written and verbal expression of ideas, an active/proactive communicator
- Good interpersonal skills, ability to successfully interact with and influence with a wide range of people
- Customer orientation awareness and focus
- Experience of working successfully in a team and managing multiple priorities